Metering system and method of trastuzumab for injection
By establishing a patient information database and deep learning algorithm to plan the dosage plan, monitoring blood drug concentration and left ventricular ejaculation fraction in real time, dynamically adjusting the dosage amount, and reasonably managing the remaining drugs, the problems of inaccurate calculation of trastuzumab dose and poor management of the remaining drugs were solved, and safer and more efficient treatment effects were achieved.
Patent Information
- Application Number
- CN202510527871.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-04-25
- Publication Date
- 2025-08-26
AI Technical Summary
The dosage calculation of trastuzumab in the prior art is inaccurate, poor management of residual drugs, and unreasonable administration frequency, resulting in poor treatment effect and safety hazards.
By establishing a patient information database, using biodata perception network and multimodal data fusion technology to collect patient information, combining deep learning algorithms to plan the dosage plan, and real-time monitoring of blood drug concentration and left ventricular ejaculation fraction, dynamically adjusting the dosage dosage, reasonably managing residual drugs, and designing the residual drug reuse process.
It has achieved the accuracy and safety of trastuzumab treatment, reduced adverse reactions, optimized the utilization of medical resources, reduced drug waste, and improved treatment effect and economicality.
Smart Images
Figure CN120544779A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of biomedicine, and in particular to a metering system and method for trastuzumab for injection. Background Art
[0002] With the continuous advancement of cancer treatment technologies, the need for precise administration of trastuzumab for injection has become increasingly prominent. In clinical practice, multiple factors influence the effectiveness of trastuzumab treatment, including significant individual differences among patients and their varying responses to the drug; complex medical settings, and the difficulty in standardizing drug storage and usage protocols. Furthermore, the treatment process requires comprehensive consideration of multiple aspects of information to develop an optimal plan, and existing technologies are insufficient in this regard.
[0003] Traditional trastuzumab dosing methods have numerous flaws. Dosage calculations rely solely on body weight or body surface area, failing to fully account for individual differences in patient disease status and underlying health conditions, leading to inaccurate dosing. Regarding drug management, the handling of excess medication lacks standardization, creating waste and safety risks. Furthermore, dosing frequency settings fail to incorporate the patient's overall condition, impacting treatment effectiveness.
[0004] In view of this, it is necessary to develop a metering system and method for trastuzumab injection to solve the problems of existing technologies in inaccurate dosage calculation, poor management of residual drugs, and unreasonable dosing frequency. By comprehensively collecting patient information and rationally planning dosing plans, safer and more efficient trastuzumab treatment can be achieved. Summary of the Invention
[0005] In view of this, the present invention proposes a metering system and method for trastuzumab injection, aiming to address the problems of existing technologies in terms of inaccurate dosage calculation, poor management of residual drugs, and unreasonable dosing frequency. By comprehensively collecting patient information and rationally planning dosing regimens, safer and more efficient trastuzumab treatment can be achieved.
[0006] In one aspect, the present invention provides a method for measuring trastuzumab for injection, comprising:
[0007] Establish a patient information database, collect the patient's basic information, disease information, basic disease information and past treatment history information based on the biological data perception network, and convert the data into unified standard structured data through multimodal data fusion technology and store it in the patient information database;
[0008] Analyzing patient information database data and the pharmacological properties of trastuzumab based on a deep learning algorithm, and planning an initial dosing regimen based on the analysis results, the initial dosing regimen including: single dose and dosing frequency;
[0009] Monitor the patient's blood drug concentration, left ventricular ejection fraction, and adverse reaction data in real time, and decide whether to suspend drug administration, adjust the single dose, and issue warning information based on the monitoring results;
[0010] Among them, the single dose is adjusted based on the comparison between the patient's blood drug concentration and the preset appropriate blood drug concentration range and the patient's adverse reactions; the decision on whether to suspend drug administration, adjust the single dose and issue an early warning message is made based on the changes in the patient's left ventricular ejection fraction;
[0011] Collect data on the remaining amount, storage time, and storage conditions of residual drugs in real time, and determine whether the residual drugs can be reused based on the residual drug data, and plan the residual drug processing process based on the judgment results;
[0012] If the remaining medicine is judged to be reusable, the intelligent planning algorithm will be used to plan the reuse process of the remaining medicine according to the patient's treatment needs and the characteristics of the medicine. The reuse process includes the reuse time, dosage and frequency of administration.
[0013] When it is determined that the remaining drugs cannot be reused, they shall be disposed of in accordance with the medical waste regulations.
[0014] Furthermore, the patient's basic information includes the patient's age, gender, and BMI; the disease information includes: disease type, disease stage, liver and kidney function indicators, HER2 expression level, whether there is metastasis, and metastasis site.
[0015] Furthermore, the process of planning the initial dosing regimen includes: adjusting the single dose and dosing frequency based on changes in the patient's weight, changes in disease severity, the response of the underlying disease to the drug, and fluctuations in physical condition;
[0016] For patients with early-stage HER2-positive breast cancer without metastasis, if the patient's BMI is within the normal range and the age is less than 50 years old, the initial dose is set at 8 mg / kg, and the dosing frequency is once every three weeks; if the BMI is high or the age is greater than 50 years old, the initial dose is set at 6 mg / kg, and the dosing frequency is once every three weeks;
[0017] For metastatic HER2-positive breast cancer, the initial dosing regimen is planned based on the number of metastatic sites and tumor burden:
[0018] When there are 1-2 metastatic sites and the tumor burden is low, the initial dose is set at 8 mg / kg, and the dosing frequency is once every two weeks;
[0019] When there are more than 3 metastatic sites and the tumor burden is high, the initial dose is set at 10 mg / kg and the dosing frequency is once every two weeks.
[0020] Furthermore, the process of adjusting the single dose according to the comparison result of the patient's blood drug concentration with the preset appropriate blood drug concentration range and the patient's adverse reactions includes:
[0021] Record and evaluate the patient's blood drug concentration every 2-3 weeks;
[0022] If the patient's blood drug concentration is lower than the preset appropriate blood drug concentration range during the cycle and the patient tolerates it well, the next dose will be increased by 10%-15%;
[0023] If the patient's blood drug concentration is higher than the preset appropriate blood drug concentration range during the cycle and the patient has adverse reactions, the next dosage will be reduced by 10%-15%.
[0024] Furthermore, the process of deciding whether to suspend drug administration, adjust the single dose, and issue a warning message based on changes in the patient's left ventricular ejection fraction includes:
[0025] Based on the time series analysis algorithm, the changing trend of the patient's left ventricular ejection fraction is predicted. When the patient's left ventricular ejection fraction shows an abnormal downward trend, an early warning message is issued and it is determined whether to suspend the drug administration and the next dosage;
[0026] Among them, the patient's left ventricular ejection fraction was recorded and evaluated every 4-6 weeks;
[0027] If the patient's left ventricular ejection fraction decreases by more than 8% during a cycle compared to before treatment, and the absolute value of the decrease is less than 50%, an early warning message will be issued, drug administration will be suspended, and the patient's cardiac function will be evaluated;
[0028] If the cardiac function assessment results are good, resume the drug administration and reduce the single dose by 10%-20%;
[0029] If the cardiac function assessment results show that the patient has a severe infusion reaction or a decrease in LVEF greater than 50%, trastuzumab treatment will be permanently discontinued.
[0030] Furthermore, the process of collecting data on the remaining amount, storage time, and storage conditions of the remaining medicine in real time, determining whether the remaining medicine can be reused based on the remaining medicine data, and planning the remaining medicine processing flow based on the determination result includes:
[0031] If the remaining amount of the remaining medicine is not less than 50% of the expected next dose, and the remaining medicine can be stored within 24 hours and the storage conditions meet the requirements of refrigeration at 2-8°C, then the remaining medicine can be reused for the next dose for the same patient, and the use of the remaining medicine should be recorded in detail;
[0032] If the remaining medicines do not meet the above conditions, they shall be disposed of in accordance with the medical waste regulations.
[0033] Furthermore, the patient information database also includes the patient's physical sign data, metabolic indicators, disease progression image data, and the patient's drug metabolism gene test results.
[0034] Furthermore, when planning the reuse process of remaining medicines, if the remaining medicines in one bottle for the same patient do not reach 50% of the expected next dose, multiple bottles of remaining medicines for the same patient can be combined and used. It is to be ensured that the combined medicine liquid of multiple bottles of remaining medicines is used up within 24 hours and meets the storage conditions of refrigeration at 2-8°C.
[0035] Compared with the prior art, the present invention has the following beneficial effects:
[0036] This method comprehensively collects multi-dimensional information on patients' diseases, physical conditions, and other aspects to establish trastuzumab dosing plans adapted to different situations, rationally adjust single-dose dosages, and properly manage residual medication. By establishing a patient information database, planning dosing frequency based on this information, adjusting single-dose dosages based on patient changes, and designing a storage and reuse process for residual medication, the method overcomes the shortcomings of traditional methods in terms of individual differences, dosage adjustment, and residual medication management, achieving a more accurate, efficient, and economical trastuzumab dosing plan.
[0037] The present invention can improve the therapeutic effect, reduce the occurrence of adverse reactions, and reduce drug waste, and has significant clinical application value.
[0038] On the other hand, the present invention also proposes a metering system for trastuzumab for injection, comprising: an information collection module, a data monitoring module, a control planning module, a drug dosage adjustment module, and a residual drug management module;
[0039] The information collection module is used to collect data on the patient's basic information, disease information, basic disease information, and past treatment history information, and transmit the data to the control planning module and the dosage adjustment module;
[0040] The data monitoring module has multiple built-in sensors and is used to monitor the patient's blood drug concentration, left ventricular ejection fraction, and adverse reactions in real time, and transmit the monitoring information to the control planning module and the drug dosage adjustment module;
[0041] The control planning module is used to plan the initial dosing regimen based on the data collected by the information collection module and the pharmacological properties of trastuzumab, and to adjust the single dosing dose and issue early warning information based on the monitoring results of the data monitoring module; and is also used to output the initial dosing regimen and the adjusted next dosing regimen to the dosage adjustment module;
[0042] The control planning module is also used to plan the reuse process of surplus drugs;
[0043] The drug dosage adjustment module is used to receive instructions from the control planning module and adjust the drug dosage according to the initial drug dosage plan and the adjusted next drug dosage plan;
[0044] The remaining medicine management module is used to collect data on the remaining amount, storage time, and storage conditions of the remaining medicine and to store and manage the remaining medicine;
[0045] The control planning module is connected to the information collection module, data monitoring module, drug dosage adjustment module and residual drug management module respectively, and controls the operation of the information collection module, data monitoring module, drug dosage adjustment module and residual drug management module.
[0046] It is understandable that the metering system and method for trastuzumab for injection in the above embodiments of the present invention have the same beneficial effects and will not be described in detail. BRIEF DESCRIPTION OF THE DRAWINGS
[0047] Various other advantages and benefits will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiment below. The accompanying drawings are for illustration purposes only and are not to be considered as limiting the present invention. The same reference symbols are used throughout the drawings to represent the same components. In the drawings:
[0048] Figure 1 A flow chart of a method for measuring trastuzumab for injection provided in an embodiment of the present invention;
[0049] Figure 2 This is a functional block diagram of a trastuzumab injection metering system provided by an embodiment of the present invention. DETAILED DESCRIPTION
[0050] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art. It should be noted that, unless there is a conflict, the embodiments of the present disclosure and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with the embodiments.
[0051] With the continuous advancement of cancer treatment technologies, the need for precise administration of trastuzumab for injection has become increasingly prominent. In clinical practice, multiple factors influence the effectiveness of trastuzumab treatment, including significant individual differences among patients and their varying responses to the drug; complex medical settings, and the difficulty in standardizing drug storage and usage protocols. Furthermore, the treatment process requires comprehensive consideration of multiple aspects of information to develop an optimal plan, and existing technologies are insufficient in this regard.
[0052] Traditional trastuzumab dosing methods have numerous flaws. Dosage calculations rely solely on body weight or body surface area, failing to fully account for individual differences in patient disease status and underlying health conditions, leading to inaccurate dosing. Regarding drug management, the handling of excess medication lacks standardization, creating waste and safety risks. Furthermore, dosing frequency settings fail to incorporate the patient's overall condition, impacting treatment effectiveness.
[0053] Therefore, a metering system and method for trastuzumab injection was developed to address the problems of existing technologies such as inaccurate dosage calculation, poor management of residual drugs, and unreasonable dosing frequency. By comprehensively collecting patient information and rationally planning dosing regimens, safer and more efficient trastuzumab treatment can be achieved.
[0054] Reference Figure 1 In some embodiments of the present application, a method for measuring trastuzumab for injection comprises:
[0055] S1. Establish a patient information database, collect the patient's basic information, disease information, basic disease information and past treatment history information based on the biological data perception network, and convert the data into unified standard structured data through multimodal data fusion technology and store it in the patient information database.
[0056] S2. Analyze the patient information database data and the pharmacological properties of trastuzumab based on a deep learning algorithm, and plan an initial dosing regimen based on the analysis results. The initial dosing regimen includes: single dose and dosing frequency.
[0057] S3. Real-time monitoring of the patient's blood drug concentration, left ventricular ejection fraction, and adverse reaction data, and based on the monitoring results, decide whether to suspend drug administration, adjust the single dose, and issue an early warning message.
[0058] S4. Collect data on the remaining amount, storage time, and storage conditions of the remaining medicine in real time, and determine whether the remaining medicine can be reused based on the remaining medicine data, and plan the processing flow of the remaining medicine based on the determination result.
[0059] Specifically, through the biological data sensing network deployed in various departments of the hospital, various types of patient information are collected. This information is converted into unified standard structured data through multimodal data fusion technology and stored in the patient information database.
[0060] Specifically, after the initial dosing regimen is planned based on the deep learning algorithm, the single dose is adjusted according to the comparison results of the patient's blood drug concentration with the preset appropriate range of blood drug concentration and the patient's adverse reactions; based on the changes in the patient's left ventricular ejection fraction, it is decided whether to suspend the drug administration, adjust the single dose, and issue an early warning message.
[0061] Specifically, during treatment, real-time monitoring equipment continuously collects data on the patient's blood drug concentration, left ventricular ejection fraction, and adverse reactions. Blood drug concentrations are assessed every 2-3 weeks. If the blood drug concentration is below the preset optimal range and the body tolerates it well, an adaptive dose adjustment algorithm is used to increase the next dose by 10%-15%. Conversely, if the blood drug concentration is above the optimal range and adverse reactions occur, the next dose is reduced by 10%-15%.
[0062] Specifically, the left ventricular ejection fraction (LVEF) is recorded and assessed every four to six weeks, and its changing trend is predicted using a time series analysis algorithm. If an abnormal downward trend in LVEF is detected, a warning message is issued promptly, and the decision to suspend drug administration and the next dose are determined accordingly.
[0063] Specifically, after each medication is taken, data on the remaining amount, storage time, and storage conditions is collected in real time. Based on this data, a determination is made as to whether the remaining medication is reusable. If the remaining medication is reusable, an intelligent planning algorithm is used to plan a reuse process for the remaining medication, including the reuse time, dosage, and frequency, based on the patient's treatment needs and medication characteristics. If the remaining medication is not reusable, it is disposed of in accordance with medical waste regulations.
[0064] It is understandable that establishing a patient information database facilitates the collection and integration of multi-dimensional patient information, providing a comprehensive and accurate data foundation for subsequent treatment plan formulation. Unified structured data facilitates storage, retrieval, and analysis, improving data utilization efficiency.
[0065] It is understandable that by combining the individual characteristics of patients and the properties of drugs, deep learning algorithms can be used to formulate personalized initial dosing plans to improve the targeted nature of treatment.
[0066] It is understandable that by continuously monitoring blood drug concentrations, left ventricular ejection fraction and adverse reactions, the dosage can be dynamically adjusted to ensure that the blood drug concentration is maintained within the effective therapeutic range, while protecting the patient's heart function and reducing the risk of adverse drug reactions.
[0067] It is understandable that it is necessary to reasonably judge whether the remaining drugs can be reused and plan the reuse process to reduce drug waste and lower treatment costs while ensuring drug safety.
[0068] This method enables personalized and precise trastuzumab dosing, improving treatment efficacy and reducing adverse reactions caused by improper medication use. Through excess drug management, it optimizes the use of medical resources, reduces patient treatment costs, and ensures medication safety.
[0069] Reference Figure 1In some embodiments of the present application, the patient's basic information includes the patient's age, gender, and BMI; the disease information includes: disease type, disease stage, liver and kidney function indicators, HER2 expression level, whether there is metastasis, and metastasis site.
[0070] It is understandable that clearly stipulating the specific content of patients' basic information and disease information will make information collection more comprehensive and standardized, which will help to accurately analyze patients' conditions and formulate appropriate treatment plans.
[0071] Reference Figure 1 In some embodiments of the present application, the process of planning the initial dosing regimen includes adjusting the single dose and dosing frequency according to changes in the patient's weight, changes in disease severity, the response of the underlying disease to the drug, and fluctuations in physical condition.
[0072] Specifically, for patients with early-stage HER2-positive breast cancer and no metastasis, if the patient's BMI is within the normal range and the age is less than 50 years old, the initial dose is set at 8 mg / kg, and the dosing frequency is once every three weeks; if the BMI is high or the age is greater than 50 years old, the initial dose is set at 6 mg / kg, and the dosing frequency is once every three weeks.
[0073] Specifically, for metastatic HER2-positive breast cancer, the initial dosing regimen is planned based on the number of metastatic sites and tumor burden: when there are 1-2 metastatic sites and the tumor burden is low, the initial dose is set at 8 mg / kg, and the dosing frequency is once every two weeks; when there are more than 3 metastatic sites and the tumor burden is high, the initial dose is set at 10 mg / kg, and the dosing frequency is once every two weeks.
[0074] It is understandable that different initial dosing regimens are formulated based on the patient's disease characteristics, such as whether there is metastasis, the number of metastatic sites, tumor burden, and individual characteristics, such as BMI and age, which fully considers the impact of multiple factors on the effect of drug treatment and makes the dosing regimen more personalized and reasonable.
[0075] It can be seen that providing differentiated initial dosing plans for different types of patients improves the accuracy of treatment plans, can better meet the treatment needs of patients, improve treatment effects, and reduce treatment problems caused by inappropriate initial doses.
[0076] Reference Figure 1 In some embodiments of the present application, the process of adjusting the single dosage based on the comparison results of the patient's blood drug concentration with the preset appropriate range of blood drug concentration and the patient's adverse reactions includes: recording and evaluating the patient's blood drug concentration every 2-3 weeks.
[0077] Specifically, if the patient's blood drug concentration during the cycle is lower than the preset appropriate blood drug concentration range and the patient's body tolerates it well, the next dosage will be increased by 10%-15%; if the patient's blood drug concentration during the cycle is higher than the preset appropriate blood drug concentration range and the patient has adverse reactions, the next dosage will be reduced by 10%-15%.
[0078] It is understandable that blood drug concentrations should be recorded and evaluated regularly, and the dosage should be adjusted dynamically based on the patient's physical tolerance and adverse reactions to maintain blood drug concentrations within an effective and safe range, ensuring that the drug has the best therapeutic effect.
[0079] It can be seen that through this dynamic adjustment method, the dosage can be optimized in a timely manner according to the individual drug metabolism of the patient, which not only ensures the therapeutic effect, but also reduces the adverse reactions caused by abnormal blood drug concentrations, and improves the safety and effectiveness of the treatment.
[0080] Reference Figure 1 In some embodiments of the present application, the process of deciding whether to suspend drug administration, adjust the single drug dosage, and issue a warning message based on changes in the patient's left ventricular ejection fraction includes: predicting the changing trend of the patient's left ventricular ejection fraction based on a time series analysis algorithm; when the patient's left ventricular ejection fraction shows an abnormal downward trend, issuing a warning message and determining whether to suspend drug administration and the next drug dosage.
[0081] Specifically, the patient's left ventricular ejection fraction is recorded and evaluated every 4-6 week cycle; when the patient's left ventricular ejection fraction decreases by more than 8% compared with before treatment during the cycle, and the absolute value of the decrease is less than 50%, an early warning message is issued, medication is suspended, and the patient's cardiac function is evaluated.
[0082] Specifically, if the cardiac function assessment results are good, the medication will be resumed and the single dose will be reduced by 10%-20%; if the cardiac function assessment results show that the patient has a severe infusion reaction or the LVEF decreases by more than 50%, trastuzumab treatment will be permanently stopped.
[0083] It is understandable that the left ventricular ejection fraction should be monitored regularly to detect changes in heart function in a timely manner. When an abnormal decline occurs, the drug should be suspended and evaluated to avoid further damage to the heart caused by the drug; for severe infusion reactions, permanent drug discontinuation measures should be taken to ensure the patient's life safety.
[0084] It can be seen that this measurement method can effectively prevent and control the adverse reactions of trastuzumab to the heart, promptly detect and treat abnormal heart function, reduce the risk of cardiac complications, and protect the patient's heart health and life safety.
[0085] Reference Figure 1In some embodiments of the present application, data on the remaining amount, storage time, and storage conditions of the remaining medicine are collected in real time, and whether the remaining medicine can be reused is determined based on the data of the remaining medicine, and the processing flow of the remaining medicine is planned based on the judgment result, including: if the remaining amount of the remaining medicine is not less than 50% of the expected next dosage, and the storage time of the remaining medicine is within 24 hours and the storage conditions meet the requirements of refrigeration at 2-8°C, then it is determined that the remaining medicine can be reused for the next dosage of the same patient, and the use of the remaining medicine is recorded in detail; if the remaining medicine does not meet the above conditions, the remaining medicine is disposed of in accordance with the medical waste specifications.
[0086] It is understandable that it is necessary to set clear standards for the reuse of surplus drugs, collect and judge the relevant data on surplus drugs, and rationally utilize surplus drug resources while ensuring drug safety; standardize the handling of non-reusable surplus drugs to prevent safety hazards caused by medical waste.
[0087] It can be seen that this measurement method realizes the rational use of surplus drugs, reduces drug waste, and reduces medical costs; strict reuse standards and standardized processing procedures ensure the safety of patients' medication and avoid medical problems caused by improper use of surplus drugs.
[0088] Reference Figure 1 In some embodiments of the present application, the patient information database also includes the patient's physical sign data, metabolic indicators, disease progression image data, and the patient's drug metabolism gene test results.
[0089] Specifically, in addition to basic information and disease information, the patient database also collects Ms. Zhou's vital signs data, such as body temperature, blood pressure, heart rate, etc.; metabolic indicators, such as blood sugar and blood lipids; disease progression image data, such as CT and MRI images;
[0090] It is understandable that collecting more dimensional patient information can comprehensively reflect the patient's physical condition and disease progression, and combining it with the results of drug metabolism gene testing to deeply analyze the patient's metabolism and response characteristics to drugs, can provide richer data support for personalized treatment.
[0091] It can be seen that this measurement method makes the formulation and adjustment of treatment plans more accurate, fully considers individual differences among patients, improves treatment effects, reduces adverse reactions caused by irrational medication, and achieves more scientific and effective personalized medicine.
[0092] Reference Figure 1 In some embodiments of the present application, when planning the reuse process of remaining medicines, if the remaining medicines in one bottle for the same patient do not reach 50% of the expected next dose, multiple bottles of remaining medicines for the same patient can be combined and used, wherein it is ensured that the combined medicine liquid of the multiple bottles of remaining medicines is used up within 24 hours and meets the storage conditions of refrigeration at 2-8°C.
[0093] It is understandable that after a certain treatment, a patient may have multiple bottles of leftover medicine, and the remaining amount of a single bottle may not reach 50% of the expected next dose. However, after combining multiple bottles of leftover medicine, the remaining amount meets the requirements, and the combined medicine solution is ensured to be used up within 24 hours. When the storage conditions meet the requirements of refrigeration at 2-8°C, these leftover medicines can be combined and used for the patient's next dose, and the usage should be recorded in detail.
[0094] It is understandable that on the basis of meeting the safety conditions for the reuse of surplus drugs, flexible use of multiple bottles of surplus drugs can improve the utilization rate of surplus drugs, further reduce drug waste, and at the same time ensure the safety and effectiveness of the combined drug solution.
[0095] It can be seen that this measurement method maximizes the use of surplus drug resources and reduces medical costs; reasonable combined use rules and strict storage conditions requirements ensure the safety of patients' medication and avoid medical risks caused by improper combined use of surplus drugs.
[0096] As can be seen, the present invention comprehensively collects multi-dimensional information such as the patient's disease and physical condition to establish a trastuzumab dosing plan adapted to different situations, rationally adjusts the single dose, and properly manages the problem of residual drug. By establishing a patient information database, planning the dosing frequency based on this information, adjusting the single dose based on patient changes, and designing a storage and reuse process for residual drug, the shortcomings of traditional methods in terms of individual difference considerations, dosage adjustment, and residual drug management are overcome, achieving a more accurate, efficient, and economical trastuzumab dosing plan.
[0097] It can be seen that the present invention can improve the therapeutic effect, reduce the occurrence of adverse reactions, and reduce drug waste, and has significant clinical application value.
[0098] In another preferred embodiment based on the above embodiment, refer to Figure 2 As shown, this embodiment provides a metering system for trastuzumab for injection, including: an information collection module, a data monitoring module, a control planning module, a drug dosage adjustment module, and a residual drug management module.
[0099] Specifically, the information collection module is used to collect data on the patient's basic information, disease information, basic disease information, and past treatment history information, and transmit the data to the control planning module and the dosage adjustment module.
[0100] Specifically, the data monitoring module has multiple built-in sensors. The data monitoring module is used to monitor the patient's blood drug concentration, left ventricular ejection fraction, and adverse reactions in real time, and transmit the monitoring information to the control planning module and the drug dosage adjustment module;
[0101] Specifically, the control planning module is used to plan the initial dosing regimen based on the data collected by the information collection module and the pharmacological properties of trastuzumab, and to adjust the single dose and issue early warning information based on the monitoring results of the data monitoring module; it is also used to output the initial dosing regimen and the adjusted next dosing regimen to the dose adjustment module;
[0102] Specifically, the control planning module is also used to plan the reuse process of surplus drugs;
[0103] Specifically, the drug dosage adjustment module is used to receive instructions from the control planning module and adjust the drug dosage according to the initial drug dosage plan and the adjusted next drug dosage plan;
[0104] Specifically, the residual medicine management module is used to collect data on the remaining amount, storage time, and storage conditions of residual medicines and to store and manage residual medicines;
[0105] Specifically, the control planning module is connected to the information collection module, the data monitoring module, the dosage adjustment module and the residual medicine management module respectively, and controls the operation of the information collection module, the data monitoring module, the dosage adjustment module and the residual medicine management module.
[0106] It is understandable that in the above embodiments of the present invention, the metering system and method for trastuzumab for injection have the same beneficial effects and will not be described in detail.
[0107] Those skilled in the art will appreciate that the embodiments of the present application may be provided as methods, systems, or computer program products. Therefore, the present application may take the form of a complete hardware embodiment, a complete software embodiment, or a combination of software and hardware embodiments. Furthermore, the present application may take the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to magnetic disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.
[0108] The present application is described with reference to the flowcharts and / or block diagrams of the methods, devices (systems) and computer program products according to the embodiments of the present application. It should be understood that each process and / or box in the flowchart and / or block diagram, as well as the combination of the processes and / or boxes in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device generate instructions for implementing the processes in the flowchart and / or block diagram. Figure 1 a process or multiple processes and / or boxes Figure 1 A device that provides the functions specified in a block or multiple blocks.
[0109] These computer program instructions may also be stored in a computer readable memory that can direct a computer or other programmable data processing device to work in a specific manner, so that the instructions stored in the computer readable memory produce an article of manufacture comprising an instruction device, which implements the process Figure 1 a process or multiple processes and / or boxes Figure 1 The function specified in one or more boxes.
[0110] These computer program instructions can also be loaded onto a computer or other programmable data processing device so that a series of operational steps are executed on the computer or other programmable device to produce a computer-implemented process, thereby providing the instructions executed on the computer or other programmable device for implementing the process. Figure 1 a process or multiple processes and / or boxes Figure 1 A step that specifies a function in one or more boxes.
[0111] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, ordinary technicians in the field should understand that the specific implementation methods of the present invention can still be modified or replaced by equivalents. Any modification or equivalent replacement that does not depart from the spirit and scope of the present invention should be covered by the scope of protection of the claims of the present invention.
Claims
1. A method for measuring trastuzumab for injection, characterized in that: Establish a patient information database, collect the patient's basic information, disease information, basic disease information and past treatment history information based on the biological data perception network, and convert the data into unified standard structured data through multimodal data fusion technology and store it in the patient information database; Analyzing patient information database data and the pharmacological properties of trastuzumab based on a deep learning algorithm, and planning an initial dosing regimen based on the analysis results, the initial dosing regimen including: single dose and dosing frequency; Monitor the patient's blood drug concentration, left ventricular ejection fraction, and adverse reaction data in real time, and decide whether to suspend drug administration, adjust the single dose, and issue warning information based on the monitoring results; Among them, the single dose is adjusted based on the comparison between the patient's blood drug concentration and the preset appropriate blood drug concentration range and the patient's adverse reactions; the decision on whether to suspend drug administration, adjust the single dose and issue an early warning message is made based on the changes in the patient's left ventricular ejection fraction; Collect data on the remaining amount, storage time, and storage conditions of residual drugs in real time, and determine whether the residual drugs can be reused based on the residual drug data, and plan the residual drug processing process based on the judgment results; If the remaining medicine is judged to be reusable, the intelligent planning algorithm will be used to plan the reuse process of the remaining medicine according to the patient's treatment needs and the characteristics of the medicine. The reuse process includes the reuse time, dosage and frequency of administration. When it is determined that the remaining drugs cannot be reused, they shall be disposed of in accordance with the medical waste regulations.
2. The method for measuring trastuzumab for injection according to claim 1, wherein: The patient's basic information includes the patient's age, gender, and BMI; the disease information includes: disease type, disease stage, liver and kidney function indicators, HER2 expression level, presence of metastasis, and metastasis site.
3. The method for measuring trastuzumab for injection according to claim 2, wherein: The process of planning the initial dosing regimen includes: adjusting the single dose and dosing frequency according to the patient's weight changes, disease severity changes, response of the underlying disease to the drug, and fluctuations in physical condition; For patients with early-stage HER2-positive breast cancer without metastasis, if the patient's BMI is within the normal range and the age is less than 50 years old, the initial dose is set at 8 mg / kg, and the dosing frequency is once every three weeks; if the BMI is high or the age is greater than 50 years old, the initial dose is set at 6 mg / kg, and the dosing frequency is once every three weeks; For metastatic HER2-positive breast cancer, the initial dosing regimen is planned based on the number of metastatic sites and tumor burden: When there are 1-2 metastatic sites and the tumor burden is low, the initial dose is set at 8 mg / kg, and the dosing frequency is once every two weeks; When there are more than 3 metastatic sites and the tumor burden is high, the initial dose is set at 10 mg / kg and the dosing frequency is once every two weeks.
4. The method for measuring trastuzumab for injection according to claim 2, wherein: The process of adjusting the single dose based on the comparison of the patient's blood drug concentration with the preset appropriate blood drug concentration range and the patient's adverse reactions includes: Record and evaluate the patient's blood drug concentration every 2-3 weeks; If the patient's blood drug concentration is lower than the preset appropriate blood drug concentration range during the cycle and the patient tolerates it well, the next dose will be increased by 10%-15%; If the patient's blood drug concentration is higher than the preset appropriate blood drug concentration range during the cycle and the patient has adverse reactions, the next dosage will be reduced by 10%-15%.
5. The method for measuring trastuzumab for injection according to claim 2, wherein: The process of deciding whether to suspend drug administration, adjust the single dose, and issue an early warning message based on changes in the patient's left ventricular ejection fraction includes: Based on the time series analysis algorithm, the changing trend of the patient's left ventricular ejection fraction is predicted. When the patient's left ventricular ejection fraction shows an abnormal downward trend, an early warning message is issued and it is determined whether to suspend the drug administration and the next dosage; Among them, the patient's left ventricular ejection fraction was recorded and evaluated every 4-6 weeks; If the patient's left ventricular ejection fraction decreases by more than 8% during a cycle compared to before treatment, and the absolute value of the decrease is less than 50%, an early warning message will be issued, drug administration will be suspended, and the patient's cardiac function will be evaluated; If the cardiac function assessment results are good, resume the drug administration and reduce the single dose by 10%-20%; If the cardiac function assessment results show that the patient has a severe infusion reaction or a decrease in LVEF greater than 50%, trastuzumab treatment will be permanently discontinued.
6. The method for measuring trastuzumab for injection according to claim 1, characterized in that: The process of collecting data on the remaining amount, storage time, and storage conditions of residual drugs in real time and determining whether the residual drugs can be reused based on the residual drug data includes: If the remaining amount of the remaining medicine is not less than 50% of the expected next dose, and the remaining medicine can be stored within 24 hours and the storage conditions meet the requirements of refrigeration at 2-8°C, then the remaining medicine can be reused for the next dose for the same patient, and the use of the remaining medicine should be recorded in detail; If the remaining drugs do not meet the above conditions, they are judged to be non-reusable and must be disposed of in accordance with medical waste regulations.
7. The method for measuring trastuzumab for injection according to claim 1, characterized in that: The patient information database also includes the patient's physical sign data, metabolic indicators, disease progression image data, and the patient's drug metabolism gene test results.
8. The method for measuring trastuzumab for injection according to claim 6, characterized in that: When planning the reuse process of leftover medicine, if the leftover medicine in one bottle for the same patient does not reach 50% of the expected next dose, multiple bottles of leftover medicine for the same patient can be combined and used. However, ensure that the combined liquid from multiple bottles of leftover medicine is used up within 24 hours and meets the storage conditions of refrigeration at 2-8°C.
9. A metering system for trastuzumab for injection, applicable to the metering method for trastuzumab for injection according to any one of claims 1 to 8, characterized in that: include: Information collection module, data monitoring module, control planning module, drug dosage adjustment module and residual drug management module; The information collection module is used to collect data on the patient's basic information, disease information, basic disease information, and past treatment history information, and transmit the data to the control planning module and the dosage adjustment module; The data monitoring module has multiple built-in sensors and is used to monitor the patient's blood drug concentration, left ventricular ejection fraction, and adverse reactions in real time, and transmit the monitoring information to the control planning module and the drug dosage adjustment module; The control planning module is used to plan the initial dosing regimen based on the data collected by the information collection module and the pharmacological properties of trastuzumab, and to adjust the single dosing dose and issue early warning information based on the monitoring results of the data monitoring module; and is also used to output the initial dosing regimen and the adjusted next dosing regimen to the dosage adjustment module; The control planning module is also used to plan the reuse process of surplus drugs; The drug dosage adjustment module is used to receive instructions from the control planning module and adjust the drug dosage according to the initial drug dosage plan and the adjusted next drug dosage plan; The remaining medicine management module is used to collect data on the remaining amount, storage time, and storage conditions of the remaining medicine and to store and manage the remaining medicine; The control planning module is connected to the information collection module, data monitoring module, drug dosage adjustment module and residual drug management module respectively, and controls the operation of the information collection module, data monitoring module, drug dosage adjustment module and residual drug management module.